Study of Imatinib (Glivec) in Patients With Adenoid Cystic Carcinoma of the Head and Neck

Cancer of the Head and Neck Clinical Trial

Official title:

Phase II Study of Imatinib (Glivec) Administered as a Daily Oral Treatment in Patients With Recurrent/Metastatic Adenoid Cystic Carcinoma of the Head and Neck Overexpressing KIT

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00180921
• Other study ID #: CSTI BFR 17
• Status: Recruiting
• Phase: Phase 2
• First received: September 13, 2005
• Last updated: September 24, 2007
• Start date: July 2004

Study information

• Verified date: September 2006
• Source: Gustave Roussy, Cancer Campus, Grand Paris
• Contact: Sandrine Faivre, MD
• Phone: 33 1 40 87 50 25
• Email: s.faivre[@]bjn.aphp.fr
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial Summary

This is a Phase II study of imatinib (Glivec) administered as a daily oral treatment in patients with recurrent/metastatic adenoid cystic carcinoma of the head and neck overexpressing KIT.

Description:

Patients with relapsing and/or metastatic adenoid cystic carcinoma of the salivary gland of the head and neck are usually poor responders to conventional cytotoxic chemotherapy.

The investigation of proliferation pathways involving tyrosine kinase receptors such as c-kit receptor (KIT) and PDGF receptor may allow to identify a molecular target for novel therapeutic approaches in patients with adenoid cystic carcinoma who failed locoregional treatment.

Several publications in the literature and the pathological study we conducted in Institut Gustave Roussy show that KIT overexpression is observed in at least 80-90% of the cases of adenoid cystic carcinoma, supporting the investigation of imatinib in patients with adenoid cystic carcinoma overexpressing KIT.

Imatinib is an orally administrated, well tolerated compound that could be given on an outpatient schedule to patients with relapsing/metastatic adenoid cystic carcinoma of the head and neck.

Because of the infrequent occurrence of salivary gland malignancies, a multicenter trial will be mandatory and the study will include at least 2 centers represented by Institut Gustave Roussy, Villejuif; and Hôpital Georges-Pompidou, Paris.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Histologically or cytologically proven adenoid cystic carcinoma overexpressing KIT (by immunohistochemistry) with recurrent disease documented by computed tomography (CT) scan or magnetic resonance imaging (MRI).

• Presence of at least one dimensionally measurable target lesion (contrast enhancing lesion with the largest diameter >= 2 cm, based on CT or MRI scan done within 4 weeks before the start of treatment).

• Patients able to swallow an oral compound.

• World Health Organization (WHO) performance status < 2.

• Life expectancy of >= 3 months.

• Aged >= 18 years.

• Normal hematological (neutrophils >= 1.5 x 10^9 cells/l, platelets >= 100 x 10^9 cells/l), hepatic (bilirubin < 1.5 times the upper limit of the normal range; alkaline phosphatase and transaminases <= 2.5 x the upper limit of the normal range) and renal (serum creatinine <= 150 mmol/l) functions.

• Written informed consent.

Exclusion Criteria:

• Abnormal cardiac function with history of ischaemic heart disease in the past 6 months and/or abnormal 12 lead electrocardiogram (ECG).

• Previous or current malignancies at other sites with the exception of cone biopsied carcinoma of the cervix and adequately treated basal or squamous cell skin carcinoma.

• Concomitant treatment with warfarin or any other anticoagulants.

• Unstable systemic diseases or active uncontrolled infections.

• Patients (male and female) not using effective contraception if of reproductive potential.

• Females pregnant or lactating or positive beta human chorionic gonadotropin (bHCG) at baseline

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cancer of the Head and Neck
• Carcinoma
• Carcinoma, Adenoid Cystic
• Head and Neck Neoplasms

Intervention

Drug:
• Imatinib

Locations

Country	Name	City	State
France	Institut Gustave Roussy	Villejuif

Sponsors (1)

Lead Sponsor	Collaborator
Gustave Roussy, Cancer Campus, Grand Paris

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To assess progression-free survival under treatment with imatinib mesylate in patients with relapsing/metastatic adenoid cystic carcinoma of the head and neck overexpressing KIT.		at 6 months
Secondary	The secondary objectives are to estimate the objective response rate (Response Evaluation Criteria in Solid Tumors [RECIST] criteria), disease control and overall survival.